Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Early acute kidney injury after transcatheter aortic valve implantation: predictive value of currently available risk scores.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a frequent complication associated with adverse outcomes and mortality. Various scores have been developed to predict this complication in the coronary setting. However, none have ever been tested in a large TAVI population. This study aimed to evaluate the power of four different scores in predicting AKI after TAVI. METHODS: Overall, 1535 consecutive TAVI patients from the observational multicentric "Magna Graecia" TAVI registry were included in the analysis. Of the study population, 235 (15.31%) developed AKI early. The Mehran, William Beaumont Hospital, CR4EATME3AD3, and ACEF scores were calculated retrospectively. RESULTS: The patients who developed TAVI-related AKI had significantly higher absolute values of all risk scores than those who did not. The receiver-operating characteristic analysis also showed a significant correlation between these four scores and AKI, but without a significant difference among all of them (p value = 0.176). Nevertheless, based on their area under the curve values (≤0.604 for all), none had adequate diagnostic accuracy in predicting TAVI-related AKI. Importantly, multivariate analysis identified myocardial revascularization close to the TAVI procedure and implantation of self-expanding prostheses, as well as atrial fibrillation, low-osmolar contrast media administration, corrected contrast medium volume, and any transfusion (p value < 0.05 for all) as independent risk factors for AKI. CONCLUSIONS: Although high values of current AKI risk scores are significantly associated with the development of this complication, these are not sufficiently accurate. Further studies are needed so that a TAVI-dedicated AKI risk score may be created.

MitraClip™ implantation plus left atrial appendage occlusion in a hereditary hemorrhagic telangiectasia patient.

Hereditary hemorrhagic telangiectasia is regarded as a high hemorrhagic risk condition, and the management of anticoagulation and heart surgery in these patients can be challenging. The authors describe a combined percutaneous treatment of mitral regurgitation and left atrial appendage occlusion in a patient affected by hereditary hemorrhagic telangiectasia and atrial fibrillation, supporting the safety and feasibility of the procedure and the optimal short-term outcome.

Hereditary hemorrhagic telangiectasia is a disease that carries a high risk of bleeding because of the growth of blood vessels with weak walls. The authors describe the case of a patient with hereditary hemorrhagic telangiectasia needing an intervention for mitral valve regurgitation and anticoagulation therapy for atrial fibrillation. To reduce the bleeding risk, two innovative techniques were used: the mitral valve disease was treated with the percutaneous implantation of stitches without open chest surgery and the left atrial appendage was contextually occluded thanks to another mini-invasive procedure to avoid the need for anticoagulation.

Safety of reduced or absent antithrombotic therapy after left atrial appendage closure in patients affected by hereditary hemorrhagic telangiectasia and atrial fibrillation.

BACKGROUND: Left atrial appendage (LAA) closure represents a novel therapeutic chance for patients with contraindications to long-term anticoagulation therapy, such as those affected by hereditary hemorrhagic telangiectasia (HHT) and atrial fibrillation (AF). Nevertheless, current experts' indications suggest the postprocedural administration of antithrombotic therapies to minimize the residual thromboembolic risk due to AF and to the need for device endothelialization. The aim of our study was to investigate the safety and effectiveness of LAA closure in preventing arterial thromboembolism in a very high-bleeding risk group, such as HHT patients, who are at risk not to tolerate even the mild postprocedural antithrombotic therapy usually recommended. METHODS: Eight HHT-affected patients with non-valvular AF, high-bleeding risk and/or known intolerance to antiplatelet and anticoagulant therapy were treated with interventional LAA occlusion with the Amplatzer™ Cardiac Plug™ and Amplatzer™ Amulet™ devices. Device implantation was successful in all patients. RESULTS: Postprocedural antiplatelet/anticoagulation therapy was attempted in seven patients: adherence to therapy exceeded 6 months only for one, while four patients suspended all antithrombotic medications within 30 days from the procedure due to an increase in bleeding frequency and/or severity and the other two discontinued treatment within 6 months; a single patient was not prescribed any antithrombotic therapy. At a medium follow-up of 22.4±14.3 months no thromboembolic episodes attributable to AF or device related thrombosis were reported. Two deaths were recorded 1231 and 783 days after the procedure which were classified as unrelated to any cerebral or cardiovascular accident. CONCLUSIONS: Our study suggests that the percutaneous LAA closure in HHT patients with AF could be safe and effective in preventing arterial systemic thromboembolism, also in the presence of reduced or absent postinterventional antithrombotic treatment. LAA occluder implantation can represent a valid and potentially life-saving alternative to lifelong anticoagulant therapy in HHT, as in other very high-bleeding risk patients.

Hemostasis alterations in patients with acute aortic dissection.

BACKGROUND: Surgery for acute aortic dissection (AAD) is frequently complicated by excessive postoperative bleeding and blood product transfusion. Blood flow through the nonendothelialized false lumen is a potential trigger for the activation of the hemostatic system; however, the physiopathology of the aortic dissection induced coagulopathy has never been precisely studied. The aim of the present study is the evaluation of the coagulation and fibrinolytic systems and platelet activation in patients undergoing surgery for AAD. METHODS: Eighteen patients undergoing emergent surgery for Stanford type A AAD were enrolled in the study. The activation of the coagulation and fibrinolytic systems and platelet activation were evaluated at 6 different time points before, during, and after the operation, measuring prothrombin fragment 1.2 (F1.2), plasmin-antiplasmin complex, and platelet factor 4, respectively. RESULTS: All measured biomarkers were increased before, during, and after the operations indicating a systemic activation of coagulation, fibrinolysis, and platelets. These changes were pronounced even preoperatively (T0), and soon after the beginning of cardiopulmonary bypass (T1) when the influence of hypothermia and prolonged cardiopulmonary bypass time were not yet involved. Time from symptom onset to intervention inversely correlated with preoperative F1.2 (r=-0.75; p=0.002) and plasmin-antiplasmin levels (r=-0.57; p=0.034). CONCLUSIONS: Blood flow through the false lumen is a powerful activator of the hemostatic system even before the operation. This remarkable activation may influence postoperative outcome of AAD patients.

A European multicentre, randomised study of the MAR-Tyn cobalt chromium tin-coated stent in patients with de novo coronary artery lesions: study design and protocol.

AIMS: The aim of this randomised study is to evaluate the efficacy and safety of a new bare metal stents (BMS) with thin struts and a novel passive coating as compared to current standard BMS. METHODS AND RESULTS: We designed an international, multicentre, randomised trial planned to include 160 patients assigned to receive either the titanium-nitride coated MAR-tyn stent (International Biomedical Systems, Trieste, Italy) or the Vision stent (Abbott Vascular, Abbott Laboratories, Abbott Park, IL, USA). Patients with left main or bypass graft disease, complex coronary lesions, needing treatment of multiple lesions, with recent myocardial infarction, prior BMS in or within 5 mm of the target lesion, left ventricular ejection fraction < or =25% and at increased bleeding risk are excluded. All patients are treated with dual antiplatelet therapy for two months. The primary endpoint is in-stent late luminal loss (LL) at 6-month follow-up angiography. Secondary endpoints are the incidence of major adverse cardiovascular events (MACE) and stent thrombosis over 12 months after randomisation. Patients' enrolment is open in all centres. CONCLUSIONS: This study will address the important question of safety and efficacy of a novel, inert and highly compatible passive coating on a thin-strut BMS with a great potential to be superior to a non-coated widely used BMS.

Isthmus endoprosthesis stent-graft treatment: implantation of relay dedicated device.

Among the 123 patients treated in our department by endovascular stent graft, 113 (91.8%) were identified as having involvement of the isthmus. Therefore, the incorrectly defined descending aortic disease is essentially a pathology of the isthmus that represents the distal portion of the arch. The key to the treatment of all types of aortic lesions rests on understanding the morphology of this region gifted with a "double S" configuration. Current thoracic devices are noncompliant systems and should be modified greatly, taking into account that the media of the aorta has a semi-compliant behavior. The resultant of power transmission is oriented at 45 degrees and produces a transmural radial force that animal implantation has demonstrated to be a torsional movement. The improvements in new devices actually result in a new generation of endoprostheses that seem to be closely related to the anatomy of the patient by increasing the conformability and, therefore, we expect an increase in durability. To test these features, we have studied a new stent graft in different settings of thoracic aortic disease. The new device should conform to current standards while simultaneously transmitting torsional forces. The dedicated delivery system should be arch-compatible, flexible but sufficiently rigid, and able to be three-dimensionally oriented. Moreover, the new stent graft should follow the three-dimensional anatomy of the "double S" configuration of the isthmus area and thus reduce the mismatch between the aorta and the device itself.

Endovascular treatment of thoracic aortic disease: four years of experience.

BACKGROUND: The aim of this retrospective study is to investigate efficacy and middle-term results of the stent graft treatment for diseases of descending thoracic aorta. METHODS AND RESULTS: From March 1999 to October 2003, 132 patients (113 male and 19 female, mean age 62+/-14 years) were enrolled. They were divided into 4 groups: aneurysms (43, group A), post-traumatic lesions (24, group B), and complicated type B dissections (43, group C). Twenty-two further patients, with chronic type B dissection and not suitable for endovascular or surgical or hybrid techniques because of multiple entry tears without difference between the true and false lumen and poor clinical conditions, were obliged to receive medical management only (group D). All patients underwent computed tomography (CT) scan and angiography as preoperative assessment. An optimal deployment with exclusion of the aneurysm and/or closure of the entry tear in dissection was achieved in 96.4% (106/110) of the patients that were discharged in good conditions within 6 days. No spinal cord injuries were observed. The follow-up (average 20.82+/-10.01 months, range 1 to 55 months), performed with serial chest CT scans, was 100% complete. No stent graft-related complications were detected, although only in 1 case, an asymptomatic rupture of the Excluder connecting bar was found with a perforation of the fabric and an intra-aortic exposition of the bar itself. In 2 patients with chronic dissection an asymptomatic type II endoleak was detected. A total of 4 hospital deaths resulted in an overall operative mortality of 3.9%. Seven patients (6.3%) died during the follow-up 5 of them for other diseases (4.5%). However, a 40.9% mortality was observed within the obliged medical treatment group. CONCLUSIONS: Endovascular treatment of thoracic aortic diseases, even in the acute phase, may represent a valid option with a low mortality rate. Moreover, the efficacy is proved in the middle-term whereas the long-term follow-up is still pending.

Stent graft treatment of thoracic aortic disease.

This study was a retrospective analysis of both the efficacy and long-term outcome of endovascular management of thoracic aortic disease. From March 1999 to August 2003, 129 patients (110 males; 19 females) were enrolled. They were divided into four groups: aneurysms (41, 5 of which acutely ruptured, Group A), post-traumatic lesions (24, 14 acute and 10 chronic, Group B) and complicated type B dissections (42, 23 acute and 19 chronic, Group C). Twenty-two of the 129 patients with chronic type B dissection, not suitable for endovascular treatment, received medical management only (Group D). All patients underwent computed tomography (CT) scan and angiography as preoperative assessment. Stent-graft systems were Talent -Medtronic, Excluder-Gore, Zenith-Cook and Endofit-Endomed, deployed by transesophageal echocardiography (TEE) monitoring. An optimal deployment with sealing of the graft was achieved in 95.3% (102/107) of the treated patients discharged in good condition within 6 days. Five patients (3 in Group A and 2 in Group C) underwent endovascular completion of the elephant trunk technique successfully. In 5 patients affected by atherosclerotic aneurysm, in a single-time procedure, we have also treated the abdominal aortic aneurysm by endovascular. No spinal cord injuries were observed. The follow up (average: 20.82+/-10.01 months), performed with serial chest CT scans, was 100% complete. No stent-graft related complications were detected. In 2 patients with chronic dissection, an asymptomatic type II endoleak was detected. A total of 4 hospital deaths resulted in an overall operative mortality rate of 3.7%. Seven patients (6.5%) died during the follow-up period, whereas a 31.8% (7/22) mortality rate (p<0.001) was observed within the medical treatment group. Endovascular treatment of thoracic aortic diseases, even in the acute phase, may represent a valid option, especially when compared to medical therapy.

Immediate versus delayed endovascular treatment of post-traumatic aortic pseudoaneurysms and type B dissections: retrospective analysis and premises to the upcoming European trial.

BACKGROUND: Stent grafting has been reported as a viable therapeutic option for the delayed treatment of traumatic rupture of the aortic isthmus as well as reconstruction of thoracic aortic dissections. We tested the hypothesis of whether immediate endovascular management offers clinical and pathological advantages over a delayed approach in patients with post-traumatic aortic pseudoaneurysms (PAPs) and Stanford type-B dissections (TBDs). METHODS: Thirty-one consecutive patients who were admitted with diagnosis of either PAP (n=10; 33.4+/-8.7 years) or TBD (n=21; 58.2+/-8.4 years) were respectively divided into 2 groups according to the timing of diagnosis and endovascular treatment after the traumatic or pathologic event: immediate ([lteq]2 weeks; PAP=6 and TBD=7) and delayed (>2 weeks; PAP=4 and TBD=14). Excluder-Gore (11 in PAP and 8 in TBD) and Talent-Medtronic (1 in PAP and 7 in TBD) endovascular stent grafts were deployed. Follow-up was performed at 3 months, 6 months, and 1 year and based on laboratory tests; chest angio-computed tomography scans of chest, abdomen, and pelvis; and transesophageal echocardiography. RESULTS: The endovascular procedure proved uneventful in all PAP patients who underwent either immediate or delayed treatment. In 1 PAP patient with delayed treatment, surgical removal of the pseudoaneurysm was still necessary because of further compression of the airway stem. All immediately treated TBD patients were also successful. However, in 8 of 13 TBD patients with delayed treatment (61.5%), a stent graft deployment was not possible because of complicated progression of the false lumen and multiple intimal entry tears: 1 patient benefited by fenestrations of the false lumen and 7 patients underwent medical therapy. One patient (8.3%) died because of retrograde dissection involving the aortic arch. All patients treated with endovascular stent grafts were discharged within 5 days. CONCLUSIONS: An immediate endovascular management of PAP and TBD patients offers important advantages such as avoidance of high-risk surgical procedures and postoperative complications with short hospital stay. Moreover, it has been observed that an immediate endovascular treatment allows a safe management of all patients with complete healing of the aortic wall and regression of the pseudoaneurysm in the PAP group and thrombosis of the false lumen in TBD patients.